A Phase 2 Study of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects with Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response with a Prior Course of Interferon Based Therapy
- Conditions
- Hepatitis C virus (HCV) infectionMedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C
- Registration Number
- EUCTR2006-004665-33-DE
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
- Male and female subjects, 18 to 70 years of age, inclusive.
- Genotype 1 (confirmed by standard testing), chronic hepatitis C. Chronic (non-acute) disease status must be confirmed by detectable plasma HCV RNA.
- Liver biopsy within 3 years of the date of the Screening Visit. - Judged to be in good health on the basis of medical history and physical examination (including vital signs and ECG), with any chronic medical conditions under stable medical control.
- Both Screening Visit 1 and Screening Visit 2 laboratory values must be within protocol specified laboratory reference ranges.
- Did not achieve SVR with at least 1 adequate prior course of Peg-IFN in combination with RBV (Peg-IFN/RBV) as defined by the protocol. Subjects must have received the last dose of Peg-IFN or RBV at least 12 weeks before the screening visit for this study.
- Must agree to use 2 methods of contraception that are highly effective, including one barrier method, during and for 24 weeks after the last dose of study drug (unless the subject is a woman of documented non-child-bearing potential). Female partners of male subjects must use the same precautions.
- Female subjects of child-bearing potential must have a negative pregnancy test at all visits (screening and predose Day 1) before the first dose of study drugs.
- Willing to refrain from the concomitant use of any medications, substances, or foods noted in Section 21.
- Able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study restrictions.
- Agree not to participate in other clinical studies for the duration of his/her participation in this trial through antiviral follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Any medical contraindications to Peg-IFN or RBV therapy.
- Prior response to therapy and failure to achieve SVR which may have been due to treatment non-compliance, in the assessment of the investigator based upon subject’s medical history.
- Participation in any clinical trial of a HCV protease inhibitor of any duration.
- Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
- History of or current evidence of decompensated liver disease defined as a prior or current history of ascites, hepatic encephalopathy, bleeding esophageal or gastric varices.
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis.
- Diagnosed or suspected hepatocellular carcinoma.
- Alcohol or drug abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
- Women who are pregnant or breast-feeding. - Male partners of women who are pregnant or breast-feeding.
- Hypersensitivity to tartrazine (yellow dye #5).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method